Menstrual Regulation
Conditions
Keywords
menstrual regulation, mifepristone, misoprostol
Brief summary
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
Detailed description
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility. The specific aims of this project are as follows: * Assess whether a uterine evacuation regimen that allows women the option of taking their misoprostol outside the facility and which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is feasible for introduction in a range of clinical settings in government facilities in Bangladesh; * Determine whether a mifepristone-misoprostol regimen for uterine evacuation is acceptable to women and providers; and * Determine what proportion of women, if offered the choice, would prefer to take misoprostol in the facility and what proportion would prefer to take it outside the facility.
Interventions
Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol
Sponsors
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be willing and able to sign consent forms; * Be eligible for menstrual regulation (MR) services according to clinician's assessment; * Be willing to undergo a surgical evacuation if necessary; * Be willing to provide a urine sample prior to administration of the mifepristone * Have ready and easy access to a telephone and * Agree to comply with the study procedures and visit schedule
Exclusion criteria
* • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass; * Chronic renal failure; * Concurrent long-term corticosteroid therapy; * History of allergy to mifepristone, misoprostol or other prostaglandin; * Hemorrhagic disorders or concurrent anticoagulant therapy; * Inherited porphyrias; or * Other serious physical or mental health conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| successful menstrual regulation without the need for a surgical evacuation | 14 days |
Countries
Bangladesh
Outcome results
None listed